Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medworks Corp. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982630 | MEDWORKS VISUALIZATION INSEMINATION CATHETER | Medworks Corp. | 1999-01-14 | 170 | 0 |
| K982628 | MEDWORKS INSEMINATION CATHETER | Medworks Corp. | 1998-08-21 | 24 | 0 |
| K982626 | URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-10 | Medworks Corp. | 1998-08-20 | 23 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda